PATIENT REPORTING OF ADVERSE DRUG REACTIONS IN POLAND AND THE NETHERLANDS: A COMPARISON OF TWO PHARMACOVIGILANCE APPROACHES AND THEIR IMPACT

Objective Adverse drug reactions (ADRs) pose a significant challenge to patient safety, and the effectiveness of pharmacovigilance systems depends to a large extent on patient engagement in reporting. The aim of this study was to compare the level of knowledge about ADRs and reporting behaviour among respondents, including patients and their caregivers, from Poland and the Netherlands. Methods A cross-sectional study was conducted using an anonymous online questionnaire incorporating skip logic. Participants were recruited using a non-probability sampling approach and, depending on their responses, completed between 11 and 17 questions. Results The results showed that Polish respondents demonstrated greater knowledge of ADRs and reporting procedures, which was reflected in higher self-reported reporting rates compared to respondents from the Netherlands. However, the proportion of individuals who declared that they had experienced ADRs in the past two years was similar in both countries. In contrast, official pharmacovigilance data indicate substantially higher reporting levels in the Netherlands, with approximately five times more reports submitted in 2024 compared to Poland. This discrepancy may suggest a gap between self-reported and actual reporting behaviour, as well as a potential overestimation of reporting activity in survey responses. Conclusion These findings indicate that although higher levels of knowledge and reporting were observed among Polish respondents, no statistically significant association between knowledge and ADR reporting was identified. This suggests that factors other than knowledge, including systemic and socio-cultural influences, may play a key role in real-world pharmacovigilance outcomes. Strengthening reporting systems and increasing patient awareness and engagement may help bridge the gap between awareness and actual reporting practices.